U.S. patent application number 13/363590 was filed with the patent office on 2013-08-01 for skin nicking device, method and assembly.
The applicant listed for this patent is Thomas Vincent Casey, II, James E. Ingold, JR.. Invention is credited to Thomas Vincent Casey, II, James E. Ingold, JR..
Application Number | 20130197558 13/363590 |
Document ID | / |
Family ID | 48870890 |
Filed Date | 2013-08-01 |
United States Patent
Application |
20130197558 |
Kind Code |
A1 |
Ingold, JR.; James E. ; et
al. |
August 1, 2013 |
SKIN NICKING DEVICE, METHOD AND ASSEMBLY
Abstract
A device, method and assembly for nicking skin is disclosed. The
device includes a lumen is that is slideable over an introducer
needle, and a blade at the end of the device. The device may
include a shield for restricting advancement of the device during a
skin nicking procedure. The device may also include a retractable
blade or guard as a safety and nicking customization feature. A
recess can also be shaped in the device for slideably attaching the
device to an introducer needle hub.
Inventors: |
Ingold, JR.; James E.;
(Hillsborough, NC) ; Casey, II; Thomas Vincent;
(Troy, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ingold, JR.; James E.
Casey, II; Thomas Vincent |
Hillsborough
Troy |
NC
NY |
US
US |
|
|
Family ID: |
48870890 |
Appl. No.: |
13/363590 |
Filed: |
February 1, 2012 |
Current U.S.
Class: |
606/185 |
Current CPC
Class: |
A61B 17/32093 20130101;
A61B 17/3415 20130101; A61B 2017/3492 20130101; A61B 17/34
20130101; A61B 2090/036 20160201 |
Class at
Publication: |
606/185 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. A device for nicking skin, the device comprising: an elongate
member having a proximal portion and a distal portion, a lumen
extending at least partially through the elongate member, wherein
the lumen is configured to be slideable over an introducer needle,
and a first blade disposed on the distal portion of the elongate
member.
2. The device of claim 1 further comprising: a shield extending
away from a longitudinal axis of the lumen, disposed proximate to a
distal portion of the blade.
3. The device of claim 2, wherein an angle between a distal surface
of the shield and the longitudinal axis of the lumen is between 15
and 70 degrees.
4. The device of claim 2, wherein the shield comprises a
transparent material.
5. The device of claim 2 further comprising: a marker disposed on
the shield corresponding to a position of the first blade.
6. The device of claim 2 further comprising: an absorbent material
disposed on a distal surface of the shield.
7. The device of claim 2, wherein the shield comprises a hinge and
a cavity for housing the first blade.
8. The device of claim 1, wherein the first blade is slideably
attached to the elongate member.
9. The device of claim 1 further comprising: a shield extending
away from a longitudinal axis of the elongate member, wherein the
shield is slideably attached to the elongate member, and wherein
the shield includes a cavity for housing at least a portion of the
first blade.
10. The device of claim 9 further comprising: an adjustment member
connected to the shield and configured for restricting a range of
movement of the shield.
11. The device of claim 1, wherein the proximal portion of the
elongate member is slideably attachable to an introducer needle
hub.
12. The device of claim 1, wherein the distal portion of the
elongate member tapers distally.
13. The device of claim 1, wherein the lumen extends through the
elongate member from a proximal end of the proximal portion to a
distal end of the distal portion.
14. The device of claim 1 further comprising: a second blade
disposed on the distal portion of the elongate member.
15. The device of claim 1 further comprising: a tactile member for
deploying the first blade from a housing below an outer surface of
the distal portion of the elongate member.
16. The device of claim 1 further comprising: a cover comprising a
proximal cover portion, a distal cover portion, and at least one
elastic member, wherein the cover coaxially surrounds at least a
portion of the blade, and wherein the distal cover portion extends
at least distally to a plane including the distal end of the first
blade.
17. A method for preparing skin for insertion of an elongate
medical device, the method comprising: providing: an introducer
needle having a proximal portion and a distal portion, and an
elongate member having a proximal portion and a distal portion, a
lumen extending at least partially through the elongate member,
wherein the lumen is configured to be slideable over the introducer
needle, and a first blade disposed on the distal portion of the
elongate member; advancing the needle to a target site below a
surface of the skin; sliding the elongate member along the
introducer needle from the proximal portion of the introducer
needle towards the distal portion of the introducer needle and
nicking the skin; and removing the needle from below the surface of
the skin.
18. The method of claim 17 further comprising: sliding the elongate
member from the distal portion of the needle towards the proximal
portion of the needle.
19. The method of claim 17, wherein the introducer needle further
comprises a hub, and wherein the proximal portion of the elongate
member is slideably attachable to the hub, the method further
comprising: obtaining the elongate member coaxially loaded over the
needle and attached to the hub; detaching the elongate member from
the hub; and reattaching the elongate member to the hub.
20. An assembly for obtaining access to a site within a lumen of a
blood vessel, the assembly comprising: an introducer needle having
a hub; and a skin nicking device comprising: an elongate member
having a proximal portion and a distal portion, wherein the
proximal portion of the elongate member is slideably attachable to
the hub, a lumen extending at least partially through the elongate
member, wherein the lumen is configured to be slideable over an
introducer needle, and a first blade disposed on the distal portion
of the elongate member; wherein the elongate member is coaxially
loaded over the needle and attached to the hub.
Description
TECHNICAL FIELD
[0001] The present invention relates generally to a device, method
and assembly for nicking skin. More specifically, the invention
relates to a skin nicking device that is slideable over an
introducer needle.
BACKGROUND OF THE INVENTION
[0002] Elongate medical devices such as introducer sheaths are
commonly used in medical procedures for gaining access to a
subcutaneous site within a human body by providing a hollow pathway
between the surface of the skin and the target site. For example,
catheter insertion procedures such as peripherally inserted central
catheter placement or midline catheter placement commonly utilize
introducer sheaths for gaining access to the lumen of a blood
vessel. A typical introducer sheath is made from a thin hollow
plastic tubular structure with a hollow opening on the insertion or
distal end and a hemostatic valve on the proximal end. Introducer
sheaths come in a variety of shapes and sizes, and medical
professionals typically select a shape and size corresponding to
the type of procedure being performed and the access site being
targeted. Introducer sheaths also include a dilator with a tapered
distal end for accommodating a smooth transition as the sheath is
advanced through a venipuncture site and into the lumen of the
blood vessel. The introducer sheath and dilator are typically
packaged together as a dilator sheath assembly.
[0003] FIGS. 1A-1E show an exemplary prior art technique for
inserting a dilator sheath assembly into the blood vessel of a
patient 10. A venipuncture is performed with a percutaneous
introducer needle 50 by inserting the needle 50 into the skin 12 at
an approximately 30-45 degree angle with the surface of the skin.
The needle 50 is advanced through tissue 14 until the tip of the
distal end 58 of the needle 50 enters the lumen of the target blood
vessel 16. Detection of flashback indicates that the tip of the
needle has entered the lumen of the blood vessel and that the tip
of the needle 50 is properly positioned. As shown in FIG. 1B, once
the needle is properly positioned with fluid access to the target
blood vessel 16, a guide wire 60 can be inserted into the proximal
end 52 of the needle, advanced to the distal end 58, advanced out
of the needle tip and into the blood vessel 16. With the guide wire
60 positioned within the blood vessel 16, the needle 50 can be
retracted off the guide wire 60, and access is maintained via the
guide wire 60 as shown in FIG. 1C.
[0004] Now with reference to FIG. 1D, a small nick 18 is made in
the skin 12 adjacent to the guide wire 60 at the venipuncture site
using a scalpel 20. By nicking the skin, an opening 18 is created
in the skin 12 for accommodating advancement of the dilator sheath
assembly 22 or other elongate medical device over the guide wire 60
and into the blood vessel 16. Without nicking the skin, the medical
professional performing the procedure may encounter significant
resistance while attempting to advance the dilator sheath assembly
22 through the skin 12. Further, if the venipuncture site is too
small, the opening 28 of the sheath 26 which coaxially surrounds
the dilator 24 may curl back or "fish mouth" as the medical
professional attempts to advance it through the skin 12, causing
damage to the sheath 26 and possibly injury to the patient 10.
[0005] More generally, nicking the skin with a scalpel is common
for procedures facilitating subcutaneous access and insertion of a
variety of elongate medical devices. For example, certain
angioplasty catheters for treatment for peripheral artery disease
are designed for direct insertion into the arterial system without
the need for a dilator sheath. Or, for example, for endovascular
laser treatment, the skin may be nicked to facilitate advancing a
procedure sheath or an optical fiber.
[0006] In the technique described above, medical professionals
typically use a scalpel to nick the skin prior to inserting the
elongate medical device, such as a dilator sheath assembly.
However, problems arise when using a scalpel to perform the step of
nicking the skin. For example, creating a small nick that is
accurately close to the venipuncture site requires precise
maneuvering of the scalpel to avoid damaging the guide wire.
Medical professionals are warned against contacting the sharp side
of the scalpel with the guide wire since it is fragile and can be
easily damaged. A damaged guide wire may require removal from the
patient or restarting the procedure with a new guide wire, further
increasing risk to the patient. Further, it is difficult to
consistently create a small nick in the skin of appropriate size.
Skin nicks that are too small will not facilitate insertion of the
elongate medical device. Conversely, excessively large nicks may
cause unnecessary bleeding and scaring in the patient. Still
further, including a scalpel as a separate component in an access
kit requires more space in the kit and adds inefficiency to the
procedure. Therefore, there is a need for an improved device,
method and assembly for accurately, consistently and efficiently
nicking the skin without risking damage to the guide wire, and
while minimizing risk of injury to the patient.
SUMMARY
[0007] The present invention is directed to a device, method and
assembly for nicking the skin using a device that is slideable over
an introducer needle.
[0008] In one embodiment, the device for nicking skin includes an
elongate member having a proximal portion and a distal portion, a
lumen extending at least partially through the elongate member,
where the lumen is configured to be slideable over an introducer
needle, and a first blade disposed on the distal portion of the
elongate member.
[0009] In another embodiment, a method for preparing skin for
insertion of an elongate medical device includes providing an
introducer needle having a proximal portion and a distal portion,
and providing an elongate member having a proximal portion, a
distal portion, and a lumen extending at least partially through
the elongate member. The lumen is configured to be slideable over
the introducer needle, and a first blade is disposed on the distal
portion of the elongate member. The needle is advanced to a target
site below a surface of the skin, and the elongate member is slid
along the introducer needle from the proximal portion of the
introducer needle towards the distal portion of the introducer
needle to nick the skin. The needle is then removed from below the
surface of the skin.
[0010] In another embodiment, an assembly for obtaining access to a
site within a lumen of a blood vessel includes an introducer needle
having a hub and a skin nicking device. The skin nicking device
includes an elongate member having a proximal portion and a distal
portion, where the proximal portion of the elongate member is
slideably attachable to the hub, a lumen extends at least partially
through the elongate member, the lumen is configured to be
slideable over an introducer needle, and a first blade is disposed
on the distal portion of the elongate member. The elongate member
is coaxially loaded over the needle and attached to the hub.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The foregoing purposes and features, as well as other
purposes and features, will become apparent with reference to the
description and accompanying figures below, which are included to
provide an understanding of the invention and constitute a part of
the specification, in which like numerals represent like elements,
and in which:
[0012] FIGS. 1A-1E illustrate a prior art technique for creating
introducer sheath access to the lumen of a blood vessel; FIG. 1A is
a side view, partially cut away, of an introducer needle advanced
into the lumen of a blood vessel; FIG. 1B is a side view, partially
cut away, of a guide wire advanced into the lumen of a blood
vessel; FIG. 1C is a side view, partially cut away, of a guide wire
with access to the lumen of a blood vessel; FIG. 1D is a side view,
partially cut away, of a scalpel nicking the skin; FIG. 1E is a
side view, partially cut away, of a dilator sheath assembly being
advanced over a guide wire;
[0013] FIG. 2 is a perspective view of a skin nicking device
according to an exemplary embodiment of the present invention;
[0014] FIG. 3 is an side view of the skin nicking device shown in
FIG. 2;
[0015] FIG. 4A is front view of the skin nicking device shown in
FIG. 2; FIG. 4B is a back view of the skin nicking device shown in
FIG. 2;
[0016] FIGS. 5A-5C show a technique for creating introducer sheath
access to the lumen of a blood vessel according to an exemplary
embodiment of the present invention; FIG. 5A is a side view,
partially cut away, of the skin nicking device shown in FIG. 2
loaded over a needle and attached to a needle hub; FIG. 5B is a
side view, partially cut away, of the skin nicking device shown in
FIG. 2 advanced into the skin and forming a skin nick; FIG. 5C is a
side view, partially cut away, of the skin nicking device being
retracted from the surface of the skin;
[0017] FIG. 6 is a perspective view of a skin nicking device with a
deployable blade according to an exemplary embodiment of the
present invention;
[0018] FIGS. 7A and 7B show side views, partially cut away of a
skin nicking device with a deployable blade according to an
exemplary embodiment of the present invention; FIG. 7A shows the
device detached from a needle hub; FIG. 7B shows the device
attached to a needle hub;
[0019] FIG. 8 is a perspective view of a skin nicking device with
an elastic cover according to an exemplary embodiment of the
present invention;
[0020] FIG. 9 is a perspective view of a skin nicking device with a
hinged shield according to an exemplary embodiment of the present
invention;
[0021] FIG. 10 is an side view of the skin nicking device shown in
FIG. 9;
[0022] FIG. 11 is an side view, partially cut away, of a skin
nicking device with a retractable blade according to an exemplary
embodiment of the present invention;
[0023] FIGS. 12A-12C show the relationship between the position of
the blade and the height of the exposed portion of the blade; FIG.
12A shows the slider at P1 and the blade retracted in the device
housing; FIG. 12B shows the slider at P2 and the exposed portion of
the blade at height H1; FIG. 12C shows the slider at P3 and the
exposed portion of the blade at height H2;
[0024] FIG. 13 is a top view of a skin nicking device with a
retractable shield according to an exemplary embodiment of the
present invention;
[0025] FIG. 14 is a side view, partially cut away, of the skin
nicking device shown in FIG. 13;
[0026] FIG. 15 is a side perspective view of an introducer needle
and skin nicking device assembly packaged in a safety guard;
and
[0027] FIG. 16 is a diagram of a method for preparing skin for
insertion of an introducer sheath.
DETAILED DESCRIPTION OF THE INVENTION
[0028] The present invention can be understood more readily by
reference to the following detailed description, the examples
included therein, and to the Figures and their following
description. The drawings, which are not necessarily to scale,
depict selected preferred embodiments and are not intended to limit
the scope of the invention. The detailed description illustrates by
way of example, not by way of limitation, the principles of the
invention. The skilled artisan will readily appreciate that the
devices and methods described herein are merely examples and that
variations can be made without departing from the spirit and scope
of the invention. It is also to be understood that the terminology
used herein is for the purpose of describing particular embodiments
only and is not intended to be limiting.
[0029] Referring now in detail to the drawings, in which like
reference numerals indicate like parts or elements throughout the
several views, in various embodiments, presented herein is a skin
nicking device, method and assembly.
[0030] FIG. 2 shows a skin nicking device according to an exemplary
embodiment of the present invention. The body of the skin nicking
device 100 is generally an elongate member made of a medical grade
material such as plastic. The outside of the device 100 has at
least one blade 102 for creating a nick in the skin. As better
illustrated in FIG. 3, a lumen 150 extends from the proximal end
112 to the distal end 104 of the device. The blade 102 is
positioned on the distal portion 104 of the device, at or near the
distal lumen opening 108 of the lumen 150. The blade 102 is exposed
to the outer surface of the distal portion 104 of the device 100 so
that as the device 100 is advanced distally over a guide wire, the
blade will contact a skin surface and nick the skin. The distal
portion 104 of the device 100 can taper distally 106 to facilitate
the creation of an opening for a dilator sheath assembly. The
proximal portion 112 of the device 100 can include concave or other
ergonomic features 110 for improved tactile feedback for the
medical professional operating the device. More than one blade can
be positioned on the distal portion 104 of the device, for example
two blades can be positioned in an opposing configuration or a "V"
configuration.
[0031] To improve accuracy regarding the depth and length of the
skin nick, a shield 114 can be positioned proximal to the blade 102
to limit how far the device 100 can be advanced into the skin. To
accommodate the typical 30-45 degree angle of insertion for the
introducer needle, the shield 114 can be angled within 30-45
degrees of the longitudinal axis of the lumen 150 so that once the
blade 102 is fully advanced into the skin, the shield is flush with
the outer surface of the skin. The blade can be made from a
transparent medical grade material so that the shield does not
block the view of the medical professional performing the
procedure. An absorbent material can also be placed on the distal
surface of the shield to absorb any blood that comes to the surface
of the skin during the nicking procedure. The device 100 can be
manufactured using manufacturing processes known in the art, for
example molding separate plastic components and assembling the
device using a snap-fit and/or ultrasonic welding process. The
blade 102 can be made of a medical grade metal such as stainless
steel or carbon steel.
[0032] FIGS. 4A and 4B show front and back views of skin nicking
device 100 respectively. As shown in FIG. 4A, the blade 102 is
positioned above the distal lumen opening 108 so that as the device
is advanced over a needle shaft, the blade has enough separation to
avoid contacting the needle shaft. FIG. 4B shows a recess 120 that
can be formed in the proximal portion 112 of the device 100 for
press fitting and attaching the device 110 onto a needle hub. Since
the device 100 can be attached to a needle hub, the device can be
offered to medical professionals as a pre-loaded assembly attached
the introducer needle. Further, press fitting the device 100 with
an introducer needle to provide a single assembly gives medical
professionals the added efficiency of performing the venipuncture
step and introducer needle retraction step without the need to
handle the nicking device 100 separately. Alternatively, the recess
can be formed in the needle hub with the proximal end of the device
100 shaped to press fit into the recess. Alternate methods known in
the art of slideably attaching the two members can be also
used.
[0033] FIG. 6 shows a skin nicking device 200 according to an
exemplary embodiment of the present invention. The distal portion
204 of the device 200 includes a housing 218 for housing the blade
202 below an outer surface of the device. A tactile feature such as
a button 216 is included for deploying and exposing the blade 202
above the surface of the device. The distal end of the blade 202
can be hinged to an inner surface of the housing 218, and the blade
202 and button 216 can be connected to each other by a lever
tensioned with springs for deploying the blade 202 when the button
216 is pressed down and returning the blade 202 to the housing 218
once the button is released.
[0034] Alternatively, as shown in FIGS. 7A and 7B, a button or
elastic element 254 can be configured to interact with the recess
256. With reference to FIG. 7A, the blade 252 is deployed from a
housing while the device 250 is detached from the needle hub 262.
The elastic element 254 is formed and positioned within the device
so that in a detached state, the blade 252 is deployed to a
pre-determined position for exposure outside the housing. Once the
device 250 is connected to the needle hub 262, the edges of the
needle hub 262 force the elastic element 254 to deform, safely
storing the attached blade 252 within the housing. The elastic
element can be for example a thin elongated metal or plastic band,
and the mounting configuration can be customized based on the
desired positioning of the blade. When a medical professional
performs the venipuncture with the device 250 attached to the
introducer needle 260 as an assembly, the blade 252 will be safely
housed within the body of the device 250. Once the medical
professional advances the device 250 off of the needle hub 262, the
elastic element 254 expands, the blade 252 is deployed, and the
skin nicking procedure can be performed. The device 250 can then be
re-attached to the needle hub 262, deforming the elastic element
254 and housing the blade 252 for safe removal of the assembly.
[0035] FIG. 8 shows a skin nicking device 300 according to an
exemplary embodiment of the present invention, including a handle
310, a shield 314, a conical distal portion 306 and a retractable
cover 322. The cover 322 coaxially surrounds the blade 302 and the
conical distal portion 306. The cover has two elastic springs 318,
320, so that once the distal opening 324 of the cover 322 hits the
skin, the cover 322 will retract proximally. Alternate types of
elastic components can be used to prop the cover past the distal
lumen opening 408 or the distal tip of the blade 402. The cover can
be made of a transparent material such as a clear plastic membrane,
so that the medical professional performing the skin nicking
procedure can view the blade entering the skin.
[0036] FIGS. 9 and 10 show a skin nicking device 400 according to
an exemplary embodiment of the present invention, including a
handle 410, a top 414 and bottom 416 shield member, a hinge 418
connecting the top 414 and bottom 416 shield member, a conical
distal portion 306, and a distal lumen opening 408. The top shield
member 414 has a cavity 420 for housing the blade 402, so that as
the top shield member 414 is swung down in the direction
illustrated in FIG. 10, the blade 402 will be safely housed and
unexposed. For multi-blade embodiments, multiple cavities or larger
cavities can be formed to accommodate the multi-blade
configuration. Additionally, multiple shield members can be hinged
and movable (e.g. closing a top and bottom shield member for a two
blades in an opposing configuration), so that all blades are housed
in a multi-blade embodiment. The proximal end 412 could also
include a recess for attaching the device to a needle hub. Thus,
the device 400 can be pre-loaded onto an introducer needle with the
top shield member closed so that-the medical professional can
safely handle the assembly without the blade exposed.
[0037] FIG. 11 shows a skin nicking device 500 according to an
exemplary embodiment of the present invention, including a proximal
portion 512, a distal portion 504, a handle 510, a tactile
slideable button 560, an extension arm 562, a blade 502, a lumen
550, a distal lumen opening 508, a tapered portion 506 and a shield
514. The blade 502 is connected to the slideable button 560 by the
extension arm 562. Referring now to FIGS. 12A-12C, the slideable
button 560 can limited to a range that allows the blade 502 to be
housed, partially exposed, or fully exposed. With the shield 514
angled to accommodate the angled entry of the introducer needle
into the venipuncture site, the nicking device 500 has the added
advantage of being able to customize the height and depth of the
nick, depending on how far distally the blade 502 is deployed. For
example, in FIG. 12A, the button 560 is in position P1, and the
blade 502 is unexposed and safely housed within the body of the
device 100. In FIG. 12B, the button 560 is slid distally to
position P2, and the blade 502 is now partially exposed to height
H1. In FIG. 12C, the button 560 is slid to an end range of position
P3, fully exposing the blade 502 to height H2. As illustrated in
FIGS. 12B and 12C, the medical professional can customize the size
of the skin nick by sliding the button 560 between positions P1 and
P3. The blade shape can also be customized (e.g. square or
circular) to create various customization effects as the blade is
distally deployed from the device housing. Further, multiple
buttons can be connected to multiple blades surrounding the lumen
so that the medical professional has various deployment options
depending on the patient's anatomy and the procedure being
performed.
[0038] Alternatively, as shown in the exemplary embodiment in FIGS.
13 and 14, the shield 664 can be slideably attached to the body of
the device 600 by a track 662, so that as the shield 64 is
retracted proximally, the blade 608 is revealed. As shown in FIG.
600, the device features a slideable button 660 attached to the
shield 664, a blade fixed to the distal portion 604 of the device
600, a proximal portion 612 with an ergonomic feature 610, a lumen
650, and a distal lumen opening 608. Following the same principals
illustrated in FIGS. 12A-12C, since the distal surface of the
shield 664 is angled acutely with respect to the longitudinal axis
of the device, as the shield 664 is retracted proximally, the
height of the exposed portion of the blade increases. Thus, medical
professionals can use the slideable button 660 to both customize
the size of the nick and house the blade 602 for safe handling.
[0039] FIG. 15 shows an introducer needle 650 and nicking device
600 as a pre-loaded assembly packaged within a safety cover 660. As
previously mentioned, the introducer needle 650 and nicking device
600 can be combined as an assembly, with the nicking device 600
coaxially pre-loaded and attached to the needle hub via a recess in
the proximal end of the nicking device. For safe storage and
transport, the assembly can include a clear safety cover 660 that
is designed to fit the needle hub 654 with clearance for the blade
602 and the shield 614 on the nicking device 600. A separate
grasping element 670 can be connected to the hub 654 for removing
the safety cover 660.
[0040] When the nicking device is obtained by medical professionals
as an assembly, a method of preparing the puncture site for
insertion of the dilator sheath assembly or other elongate medical
device can be efficiently and accurately executed as diagramed in
FIG. 16. First, the introducer needle/nicking device assembly is
obtained S1 as shown for example in FIG. 15. With the nicking
device safely secured to a hub of the needle, the venipuncture is
performed S2, and the guide wire is advanced through the needle
lumen to the target site S3 within the blood vessel. With the
nicking device readily accessible and attached to the needle hub,
the nicking device can be advanced distally by sliding it along the
shaft of the needle down to the skin, creating a nick S4. If the
nicking device had a safety or customization feature such as a
hinged shield cover or a retractable blade, the medical
professional can expose and prepare the blade for nicking prior to
advancing the device down to the skin. Alternatively, for
retractable embodiments, the device can be advanced to the surface
of the skin, and the blade can be deployed once the shield is flush
with the skin, stabilizing the skin during the nicking procedure.
Once the nick is created, the nicking device can be reattached to
the needle hub S6, and the medical professional can remove the
entire assembly by simply retracting the needle off of the guide
wire. If the device had a safety cover or retractable blade, the
blade can be housed prior to disposal of the assembly. With the
skin nicked at the venipuncture site, the dilator sheath assembly
can be loaded over the guide wire and advanced to the lumen of the
target blood vessel.
* * * * *